NCT02358798: REVOLMUCO

Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period

Completed NA Last updated 14 April 2020

What this trial tests

NA trial testing 3 years-assessment of respiratory function in Cystic Fibrosis in 40 participants. Completed in 17 January 2020.

Timeline

19 August 2014

Primary endpoint
17 January 2020

17 January 2020

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	40
Start date	19 August 2014
Primary completion	17 January 2020
Estimated completion	17 January 2020
Sites	1 location across France

Drugs / interventions tested

• 3 years-assessment of respiratory function

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University Hospital, Montpellier

Who can join

Eligibility, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.

This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.

For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.

All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.

In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.

So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.

A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.